The NRC is completing the final design and engineering work for a new permanent, GMP‑compliant clinical trial material facility at its Royalmount Avenue site in Montréal.
Intended to support vaccine and biologics development at the clinical trial stage, the new permanent clinical trial material facility will:
- enable Canadian vaccines and other biologics to advance to clinical trials in Canada
- be a product development bridge between vaccine research and development, and vaccine production of late‑stage or authorized products in large quantities elsewhere
- be a technology transfer hub to complete verification runs and optimize GMP manufacturing processes
- be an essential part of the continuum of building Canada's biomanufacturing capacity
When it is complete, the new facility will be able to produce clinical trial materials of cell‑based biologics, including viral vector, protein subunit, virus‑like particles, and other recombinant proteins.
The clinical trial material facility will have a maximum bioreactor capacity of 500 litres per month. The number of doses will vary widely, depending on the type of vaccine and its manufacturing yield.
The NRC has purchased and received equipment such as single‑use, 50‑litre and 500‑litre bioreactors. Work on quality assurance processes and framework is well underway. This involves putting in place quality assurance protocols, preparing documentation, training staff, and more.
Building on more than 30 years of experience in biomanufacturing research and development, the addition of the clinical trial material facility will enable the NRC to support 3 distinct, but complementary, stages of biomanufacturing in Canada:
- Vaccine research and development in the existing research labs
- GMP‑compliant production of clinical trial material at the new clinical trial material facility
- GMP‑compliant vaccine production at the Biologics Manufacturing Centre.
The research and development labs, clinical trial material facility and Biologics Manufacturing Centre could operate together or separately, depending on the requirements for each particular project.
Construction of the permanent clinical trial material facility is expected to be complete in fall 2022.